JP2018042856A - Transdermal administration device manufacturing method and transdermal administration device - Google Patents

Abstract

A method for producing a transdermal administration device and a transdermal administration device capable of facilitating peeling of a filling made of a material for forming an administration part from an intaglio. A method for manufacturing a transdermal administration device includes an arranging step of using an intaglio plate 30 having a recess 31 on a plate material surface 30S and arranging an auxiliary member 20 on the plate material surface 30S. The standing portion 21 of the auxiliary member 20 extends in the depth direction of the concave portion 31, and the overhang portion 22 is equally arranged on a virtual ring surrounding the concave portion 31 when viewed from the direction facing the plate material surface 30 </ b> S. Further, each of the two or more points is in contact with the plate material surface 30S and projects from the end of the standing portion 21 toward the inside of the ring. Further, the manufacturing method includes a step of filling the intaglio 30 with the forming portion forming material so as to cover the overhanging portion 22, and the auxiliary member 20 is displaced along the direction in which the standing portion 21 extends to extend the overhanging portion. A step of separating the filler Fl made of the forming material from the intaglio plate 30 by separating 22 from the plate material surface 30S. [Selection] Figure 7

Description

  The present invention relates to a transdermal administration device used for drug administration and a method for producing the same.

  As a method of administering a drug from the skin to a drug administration target, a method using a transdermal administration device is known. The transdermal administration device includes an administration part having a minute projection for piercing the skin. For example, a microneedle, which is an example of an administration unit, includes a protrusion having a needle shape that sharpens toward the tip. In the method of administering a drug using a transdermal administration device, a hole is formed in the skin by pressing the protrusion against the skin, and the drug is fed into the body of the administration target from this hole. According to such a method, it is possible to easily administer a drug without requiring a special technique for administration.

  The structure of the protrusion has a thickness suitable for piercing the skin, and a length suitable for forming a hole in the skin with a depth necessary to penetrate the drug subcutaneously. Is required. Specifically, the width of the protrusion is preferably about several μm to several hundred μm, and the length of the protrusion is preferably about several tens μm to several hundred μm.

  For example, the administration part having the protrusions includes a process of producing an original part of the administration part by machining or etching, a process of producing an intaglio plate in which the unevenness of the original plate is inverted, and a material for forming the administration part in the intaglio It is manufactured by a manufacturing method having a step of peeling the filler from the intaglio (for example, see Patent Documents 1 and 2). The filler peeled from the intaglio is the administration part. However, since the protrusion is a minute structure as described above, it is often difficult to peel the filler from the intaglio while suppressing damage to the surface of the protrusion and the surface of the intaglio. Specifically, when the magnitude and direction of the force applied to the filler and the intaglio at the time of peeling of the filler are not appropriate, the shape of the protrusions may be broken or the intaglio may be damaged.

  As a measure for facilitating peeling of the filler from the intaglio, a release agent is applied to the surface of the intaglio (for example, refer to Patent Documents 1 and 2), and a cyclic olefin resin is used as a material for forming the administration portion. Thus, it has been proposed to adjust the composition and physical properties of the forming material so as to improve the releasability of the filler (see, for example, Patent Document 3).

International Publication No. 2008/013282 International Publication No. 2008/004597 JP2013-111104A

  On the other hand, it is preferable that the forming material of the administration part that enters the skin has biocompatibility. However, the fact that the material for forming the administration part has biocompatibility imposes a great restriction on the releasability of the material for forming the administration part. Further, even in the method of applying a release agent to the intaglio, the release agent that adheres to the surface of the protrusion is preferably biocompatible. However, since there are few types of release agents having biocompatibility, there is a limit to improving the release properties by applying the release agent.

  As described above, there is a limit to improving the releasability of the filler by using only the chemical action of the mold release agent and the forming material. Therefore, as a measure to make it easier to peel off the filler from the intaglio, Measures from a viewpoint different from the manual action are desired.

  An object of the present invention is to provide a method for producing a transdermal administration device capable of easily peeling a filling made of a material for forming an administration part from an intaglio, and a transdermal administration device produced by such production method. And

A method for manufacturing a transdermal administration device that solves the above-described problem is a method for manufacturing a transdermal administration device that includes an administration part having a base having a first surface and a protrusion protruding from the first surface,
A placement step of placing an auxiliary member on the plate material surface using an intaglio plate having a recess having a concave shape following the shape of the protrusion, on the plate material surface, wherein the auxiliary member includes a standing portion and a tension member And the protruding portion extends in the depth direction of the concave portion, and the overhang portion is on a virtual ring surrounding the concave portion as viewed from the direction facing the plate material surface. It is in contact with the plate material surface at each of two or more arranged points, and from the end located on the plate material surface side of the both ends of the standing portion in the depth direction to the inside of the ring Projecting toward the surface, and filling step of filling the space in the recess and the space on the plate material with the forming material so that the forming material of the administration part covers the overhanging part. The auxiliary member is displaced relative to the intaglio along the direction in which the standing portion extends, and the overhanging portion is By separating from the wood surface, including, a peeling step of peeling the filler made of the forming material from the intaglio.

  According to the manufacturing method described above, since the filling covers the overhanging portion of the auxiliary member, the overhanging portion and the plate material surface are separated from each other along the extending direction of the uprighting portion. The packing and the plate surface are separated from each other along the extending direction of the plate. According to such a peeling mode, a force for peeling is applied to the filling material through the auxiliary member, and therefore, the force applied to the filling material can be easily controlled as compared with a method in which the filling material is directly gripped and peeled from the intaglio. Then, the protruding portion and the plate material surface are separated from each other along the extending direction of the standing portion, whereby the recessed portion and the filler can be separated from each other along the depth direction of the recessed portion. The filling material and the intaglio are prevented from being damaged by being pulled in a direction inclined with respect to the depth direction of the concave portion. Thus, according to the said manufacturing method, since it is easy to control the magnitude | size and direction of the force added to a filler and an intaglio at the time of peeling, it is easy to peel a filler from an intaglio.

The manufacturing method may include a separation step of separating the filler and the auxiliary member after the peeling step.
According to the said manufacturing method, the transdermal administration device using the filler suitably peeled from the intaglio is obtained. Therefore, a transdermal administration device having an administration part with good shape accuracy and surface condition can be obtained.

In the manufacturing method, the transdermal administration device may include the administration unit and the auxiliary member, which are the filler, as an integral structure separated from the intaglio.
According to the said manufacturing method, the auxiliary member which is a member for assisting peeling of a filler is used as a member which comprises a transdermal administration device with an administration part. Therefore, a step of separating the filling material from the auxiliary member is not necessary, and after separating the filling material from the auxiliary member, a member constituting the transdermal administration device is assembled to the administration unit as a member different from the auxiliary member. Compared with the manufacturing method, the process of assembling the members can be reduced. Therefore, the manufacturing process can be simplified and the cost required for manufacturing can be reduced.

In the manufacturing method, the projecting portion may be a single structure extending along the ring.
According to the said manufacturing method, when a filler and an auxiliary member peel from an intaglio, it is easy to ensure a large part supported by an overhang | projection part in a filler. Therefore, the filler and the auxiliary member can be peeled from the intaglio in a state where the filler is stably supported by the auxiliary member.

In the manufacturing method, the overhang portion may be composed of a plurality of structures positioned on the ring.
According to the said manufacturing method, it is easy to ensure the 1st surface in the base | substrate of the administration part formed widely. Therefore, particularly when the transdermal administration device is constructed only from the administration part by separating the filler and the auxiliary member, the first surface of the substrate is pressed against the skin for the administration of the drug, and the protrusion is applied to the skin. When piercing, the position of the substrate with respect to the skin is likely to be stable, and the protrusions are likely to pierce the skin accurately. Further, in the separation step, since the auxiliary member can be separated from the filling starting from the portion where the overhang portion is interrupted, the auxiliary member and the filling can be easily separated.

In the manufacturing method, a supplying step of supplying the forming material to the plate material surface may be performed after the arranging step.
According to the above manufacturing method, since the auxiliary member is arranged on the plate material surface in a state where the forming material of the administration part is not arranged, it is easy to align the auxiliary member on the plate material surface.

In the manufacturing method, the arranging step may be performed after the supplying step of supplying the forming material to the plate surface.
According to the said manufacturing method, compared with the manufacturing method which supplies the forming material of an administration part to the micro space enclosed by a standing part after arrangement | positioning of an auxiliary member, supply of a forming material is easy.

In the manufacturing method, the forming material is a resin, and in the filling step, the forming material may be filled by pressurization.
When the forming material of the administration part is filled into the intaglio plate by pressurization, the forming material tends to adhere to the intaglio plate, making it difficult to peel off the filler. Therefore, when the forming material of the administration part is filled into the intaglio plate by pressurization, the filling method can be easily peeled from the intaglio plate by applying the above manufacturing method in which the filling step and the peeling step are performed using the auxiliary member. The benefit of the effect is high.

In the manufacturing method, the auxiliary member may include a metal part.
According to the said manufacturing method, an auxiliary member with high mechanical strength is easy to be obtained. Therefore, it is easy to realize an auxiliary member suitable for being gripped or pulled up in the peeling process.

In the manufacturing method, the auxiliary member may include a portion made of a resin, and the portion made of the resin may include a surface in contact with the plate material surface in the arranging step in the projecting portion.
According to the said manufacturing method, the adhesiveness of an auxiliary member and a plate material surface is improved compared with the structure in which the part including the surface which contact | connects a plate material surface in an overhang | projection part is metal. Therefore, the forming material is easily filled in the region surrounded by the auxiliary member without leakage.

  A transdermal administration device that solves the above-mentioned problem is a transdermal administration device comprising an administration part comprising a base having a first surface that is a single plane and a protrusion protruding from the first surface, wherein the base Has a stepped portion extending along the outer edge of the base body and recessed from the first surface, and the stepped portion is on the ring along the outer edge of the base body as viewed from the direction facing the first surface. The first surface extends to the outer edge of the base body at a location where the step portion is interrupted.

  The transdermal administration device having the above configuration can be manufactured by the above-described manufacturing method using an auxiliary member. Therefore, a transdermal administration device using the filler suitably peeled from the intaglio is obtained. Therefore, a transdermal administration device having an administration part with good shape accuracy and surface condition can be obtained.

  A transdermal administration device that solves the above problems is a base having a first surface, the base having a step portion that is located along an outer edge of the base and is recessed from the first surface, and the first A dosing part provided with a protruding part protruding from a surface, a projecting part filling the stepped part to form one plane together with the first surface, and extending from the projecting part and outside the base An auxiliary member provided with an upright portion in contact with the first surface, and when viewed from the direction facing the first surface, the region where the overhanging portion is located on a virtual ring surrounding the protruding portion, etc. Two or more points arranged are included.

  The transdermal administration device having the above-described configuration can be manufactured by the above-described manufacturing method using the auxiliary member without requiring separation between the auxiliary member and the filler. In other words, the auxiliary member, which is a member for assisting the peeling of the filling material, is used as a member constituting the transdermal administration device together with the administration unit, and simplification of the manufacturing process is achieved, while the filling is suitably peeled from the intaglio. A transdermal administration device using the product can be obtained. Therefore, a transdermal administration device including an administration part and an auxiliary member having a good shape accuracy and surface condition can be obtained.

  ADVANTAGE OF THE INVENTION According to this invention, in the manufacturing method of a transdermal administration device, the filler which consists of a forming material of an administration part can be made easy to peel from an intaglio.

The perspective view which shows the perspective structure of the transdermal administration device of manufacture object about 1st Embodiment of the manufacturing method of a transdermal administration device. The perspective view which shows the perspective structure of the auxiliary member used with the manufacturing method of the transdermal administration device of 1st Embodiment. The figure which shows the intaglio produced by the production process of the intaglio in the manufacturing method of the transdermal administration device of 1st Embodiment. The figure which shows the arrangement | positioning process of the auxiliary member in the manufacturing method of the transdermal administration device of 1st Embodiment. The figure which shows the supply process of the forming material in the manufacturing method of the transdermal administration device of 1st Embodiment. The figure which shows the filling process of the forming material in the manufacturing method of the transdermal administration device of 1st Embodiment. The figure which shows the peeling process of the filler in the manufacturing method of the transdermal administration device of 1st Embodiment. The figure which shows the isolation | separation process of the auxiliary member in the manufacturing method of the transdermal administration device of 1st Embodiment. Sectional drawing which shows the cross-section of the transdermal administration device manufactured by the manufacturing method of the transdermal administration device of 1st Embodiment. The top view which shows the planar structure of the auxiliary member of a modification. The top view which shows the planar structure of the auxiliary member of a modification. The perspective view which shows the perspective structure of the auxiliary member of a modification. The perspective view which shows the perspective structure of the auxiliary member of a modification. The top view which shows the planar structure of the auxiliary member of a modification. The top view which shows the planar structure of the auxiliary member of a modification. The perspective view which shows the perspective structure of the auxiliary member of a modification. The perspective view which shows the perspective structure of the auxiliary member of a modification. The perspective view which shows the perspective structure of the auxiliary member of a modification. The perspective view which shows the other example of the perspective structure of the transdermal administration device manufactured by the manufacturing method of the transdermal administration device of 1st Embodiment. The perspective view which shows the perspective structure of the manufactured transdermal administration device about 2nd Embodiment of the manufacturing method of a transdermal administration device. Sectional drawing which shows the cross-section of the transdermal administration device manufactured by the manufacturing method of the transdermal administration device of 2nd Embodiment. The perspective view which shows the other example of the isometric view structure of the transdermal administration device manufactured by the manufacturing method of the transdermal administration device of 2nd Embodiment. Sectional drawing which shows the cross-section of the transdermal administration device manufactured by the manufacturing method of the transdermal administration device of 2nd Embodiment, Comprising: The transdermal administration device provided with the auxiliary member of a modification. Sectional drawing which shows the cross-section of the transdermal administration device manufactured by the manufacturing method of the transdermal administration device of 2nd Embodiment, Comprising: The transdermal administration device provided with the auxiliary member of a modification. Sectional drawing which shows the cross-section of the auxiliary member of a modification. Sectional drawing which shows the cross-section of the transdermal administration device of a modification.

(First embodiment)
With reference to FIGS. 1-19, 1st Embodiment of the manufacturing method of a transdermal administration device and the transdermal administration device manufactured by this manufacturing method are described.

[Schematic configuration of transdermal administration device]
First, a schematic configuration of a transdermal administration device that is a manufacturing target of the manufacturing method of the first embodiment will be described. The transdermal administration device produced by the production method of the first embodiment is composed of only an administration unit. With reference to FIG. 1, the structure of the microneedle which is an example of an administration part is demonstrated.

  As shown in FIG. 1, the microneedle 10 constituting the transdermal administration device 100 includes a base body 11 having a plate shape and a protrusion 12 protruding from the base body 11. The base 11 has a first surface 11S that is one surface on which the protrusions 12 are arranged, and a surface opposite to the first surface 11S, that is, a second surface 11T that is the surface farthest from the first surface 11S. The first surface 11S supports the base end of the protrusion 12.

The outer shape of the base body 11 viewed from the direction facing the first surface 11S is not particularly limited, and the outer shape of the base body 11 may be circular, elliptical, or rectangular.
The shape of the protrusion 12 may be a cone shape or a pyramid shape. Further, the protruding portion 12 may have a shape in which the tip is not sharp, for example, a cylindrical shape or a prismatic shape. Further, the protruding portion 12 may have a shape in which two or more solids are combined, such as a shape in which cones are stacked on a cylinder. In short, the protrusion 12 may have any shape that can pierce the skin. Further, a constriction or a step may be formed on the side wall of the protruding portion 12, and a hole extending in the extending direction of the protruding portion 12 may be formed in the protruding portion 12.

  The number of protrusions 12 included in the microneedle 10 is not particularly limited, and the number of protrusions 12 may be one or more. When the microneedle 10 includes a plurality of protrusions 12, each of the plurality of protrusions 12 may be arranged regularly or irregularly when viewed from the direction facing the first surface 11 </ b> S of the base 11. You may line up. For example, the plurality of protrusions 12 are arranged in a lattice shape or a concentric shape. The plurality of protrusions 12 may include protrusions 12 having different shapes.

[Configuration of auxiliary members]
With reference to FIG. 2, the structure of the auxiliary member used with the manufacturing method of 1st Embodiment is demonstrated.

As shown in FIG. 2, the auxiliary member 20 includes a cylindrical standing portion 21, and a protruding portion 22 that protrudes from one of the two cylindrical ends of the standing portion 21 toward the inside of the standing portion 21. It has.
The overhang portion 22 has a closed ring shape. The inner peripheral edge of the overhanging portion 22 defines a region larger than the region where the protruding portion 12 is located on the first surface 11S of the base body 11 of the microneedle 10. That is, when the microneedle 10 includes one protrusion 12, the opening defined by the inner peripheral edge of the protruding portion 22 has a size that allows the protrusion 12 to be disposed in the opening. Further, when the microneedle 10 includes a plurality of protrusions 12, the opening defined by the inner peripheral edge of the overhanging portion 22 stretches a set of the protrusions 12 including all the protrusions 12 arranged on the first surface 11S. The protruding portion 22 has a size that can be enclosed. The shape of the opening defined by the inner peripheral edge of the overhang portion 22 is not particularly limited, and the opening may be circular or rectangular. The shape of the opening defined by the inner peripheral edge of the overhang portion 22 matches, for example, the shape of the first surface 11S.

  The shape of the region defined by the inner peripheral edge of the standing portion 21 as viewed from the direction along which the standing portion 21 extends is not particularly limited, and the above region is, for example, the same as the outer shape of the base body 11 of the microneedle 10. Has the shape. For example, when the outer shape of the base 11 is circular, the inner peripheral edge of the standing portion 21 extends from the overhang portion 22 in a cylindrical shape. Further, for example, when the outer shape of the base body 11 is rectangular, the inner peripheral edge of the standing portion 21 extends from the overhang portion 22 in a rectangular cylindrical shape.

  The shape of the outer shape of the standing portion 21 when viewed from the direction along the direction in which the standing portion 21 extends is not particularly limited, and the outer shape of the standing portion 21 is similar to the region defined by the inner peripheral edge. Alternatively, the shape may be different from the region defined by the inner peripheral edge. For example, the outer shape of the standing portion 21 may be circular or rectangular.

  The configuration of the tube end opposite to the overhanging portion 22 in the standing portion 21 is not particularly limited, and an opening for supplying the forming material of the microneedle 10 to the inside of the standing portion 21 in the vicinity of the tube end. Should just be provided. For example, the auxiliary member 20 may be provided with a structure or the like for connecting another device or apparatus and the auxiliary member 20 to the tube end of the standing portion 21 opposite to the overhanging portion 22.

  The material for forming the auxiliary member 20 may be any material that can peel the auxiliary member 20 from the intaglio used for forming the microneedle 10 after the microneedle 10 is formed. For example, resin, metal, glass, or the like may be used. Can be mentioned. Moreover, the forming material of the auxiliary member 20 should just have the characteristic according to the process which arises in the manufacturing process of the microneedle 10. FIG. For example, when the forming material of the microneedle 10 is a thermoplastic resin and the auxiliary member 20 is heated in the manufacturing process of the microneedle 10, the auxiliary member 20 has heat resistance corresponding to the heating temperature. Just do it. For example, when the forming material of the microneedle 10 is used in an aqueous solution state, the auxiliary member 20 only needs to have water resistance.

  Further, the auxiliary member 20 may be subjected to a surface treatment for facilitating separation of the auxiliary member 20 from the filling made of the forming material of the microneedles 10 filled in the intaglio. Specifically, as surface treatment, for example, (1) formation of a release layer containing a release agent such as fluorine-based resin, metal fine particles, diamond-like carbon, silicone oil, or (2) chemical surface modification (3) Surface shape processing and the like.

[Method of manufacturing transdermal administration device]
With reference to FIGS. 3 to 8, a method of manufacturing the microneedle 10 using the auxiliary member 20 will be described as a method of manufacturing the transdermal administration device of the first embodiment.

<Intaglio production process>
As shown in FIG. 3, the intaglio 30 is used for manufacturing the microneedle 10. The intaglio plate 30 has a plate material surface 30S, which is one surface, and a recess 31 that is recessed from the plate material surface 30S. The recess 31 has a hollow shape that follows the protrusion 12 of the microneedle 10 to be manufactured, and is positioned in a direction in which the portion corresponding to the tip of the protrusion 12 becomes the bottom. The number of recesses 31 included in the intaglio 30 matches the number of protrusions 12 of the microneedle 10 that is the object of manufacture, and the arrangement of the recesses 31 matches the arrangement of protrusions 12 of the microneedle 10 that is the object of manufacture. In other words, the intaglio 30 has irregularities in which the concave and convex portions of the concave and convex portions that the microneedles 10 have on the tip side of the protrusion 12 with respect to the first surface 11S are inverted.

The outer shape and size of the intaglio 30 may be appropriately designed according to the microneedle 10 to be manufactured, other equipment used in the manufacturing process, and the like.
The material for forming the intaglio 30 is a material that can realize the mechanical strength required to transfer the shape of the recess 31 to form the microneedle 10 and the good shape followability of the filling with respect to the shape of the recess 31. I just need it. Examples of the material for forming the intaglio 30 include (1) hard brittle materials such as silicon and quartz, (2) metal materials such as nickel, aluminum, stainless steel, and titanium, (3) alumina, aluminum nitride, machinable ceramics, and the like. (4) Synthetic resins such as polyacetal, polycarbonate, polystyrene, acrylic resin, fluororesin, and silicone, and (5) polysaccharides such as alginate and chitosan.

  A known fine processing technique may be used to form the recess 31. Examples of the fine processing technique include a lithography method, a wet etching method, a dry etching method, a sand blast method, a laser processing method, a milling method, a cutting method, and a grinding method.

  Note that one intaglio plate 30 may be a plate for collectively molding a plurality of microneedles 10. That is, the plate material surface 30S of the intaglio plate 30 includes a region where each of the different microneedles 10 is formed, and a concave portion 31 corresponding to the protruding portion 12 of the microneedle 10 to be manufactured is provided in each region. It may be.

  The intaglio 30 may be produced based on an original plate having protrusions having the same shape and arrangement as the protrusions 12 included in the microneedle 10 to be manufactured. A known fine processing technique may be used for forming the original plate. Examples of the fine processing technique include a lithography method, a wet etching method, a dry etching method, a sand blast method, a laser processing method, a milling method, a cutting method, and a grinding method. The intaglio 30 is formed by inverting and transferring the shape of the original plate to the forming material of the intaglio 30 by using a plating method or applying a molten resin. By forming the intaglio plate 30 using the original plate, a plurality of intaglio plates 30 can be produced from one original plate. Therefore, the productivity of the intaglio plate 30 can be increased, and the cost required for producing the intaglio plate 30 can be reduced. .

  In addition, in order to improve the peelability between the intaglio 30 and the filler, the surface of the intaglio 30 may be subjected to a surface treatment for enhancing the releasability. Specifically, for example, surface treatment includes (1) formation of a release layer containing a release agent such as fluorine-based resin, metal fine particles, diamond-like carbon, silicone oil, and (2) chemical surface modification. (3) Surface shape processing and the like. As the release agent, a biocompatible material is preferably used.

<Auxiliary member placement process>
As shown in FIG. 4, the auxiliary member 20 is disposed on the plate material surface 30 </ b> S of the intaglio 30. In the state where the auxiliary member 20 is disposed on the plate material surface 30 </ b> S, the standing portion 21 of the auxiliary member 20 extends in the depth direction of the recess 31. And the overhang | projection part 22 is projected toward the inner side of the standing part 21 from the edge part located in the plate material surface 30S side among the both ends of the standing part 21 in the depth direction of the recessed part 31, and a plate material It is in contact with the surface 30S.

  Specifically, when viewed from the direction facing the plate material surface 30 </ b> S, the auxiliary member 20 is disposed at a position where the overhang portion 22 surrounds the recess 31. When the intaglio plate 30 has a plurality of concave portions 31, the auxiliary member 20 is disposed at a position where the overhanging portion 22 surrounds a set of all the concave portions 31 when viewed from the direction facing the plate material surface 30 </ b> S.

<Forming material supply process>
As shown in FIG. 5, the forming material Mt of the microneedle 10 is supplied to the intaglio 30. The forming material Mt is supplied to a region surrounded by the auxiliary member 20 on the plate material surface 30S of the intaglio plate 30.

  The material used as the forming material Mt of the microneedle 10 may be determined according to the use of the microneedle 10 and the characteristics required for the microneedle 10. For example, an organic material such as an acrylic resin or polycarbonate, in particular, a thermoplastic resin can be suitably used as a material for forming the microneedle 10 manufactured by the manufacturing method of the first embodiment.

  Moreover, it is preferable that the forming material of the microneedle 10 has biocompatibility. A material having biocompatibility is a material that has little harm to a living body when performing a target function, and includes a water-soluble polymer, a water-insoluble polymer, a biopolymer, a metal, and a resin. Including. For example, examples of biocompatible materials include alginate, curdlan, chitin, chitosan, glucomannan, polymalic acid, polycaprolactone, glycosaminoglycan, collagen, collagen peptide, hydroxypropylcellulose, gelatin, silicon, Examples include titanium, silicone, polylactic acid, and polyglycolic acid. Although there is no clear boundary between chitin and chitosan, in general, a substance having chitin deacetylation of 70% or more is chitosan. Deacetylation can be performed by a known method. Chitin, chitosan, and chitosan derivatives with biocompatibility may use crustacean-derived materials such as shrimp and shrimp, plant-derived materials that are produced by mycelium and microorganisms, and materials that use these as starting materials. it can. Chitosan, chitin / chitosan, and chitin / chitosan derivatives are preferable as a material for forming the microneedle 10 because they have a cosmetic effect on the skin and a bactericidal and antibacterial effect.

  Further, the forming material of the microneedle 10 may include a drug. When the protrusion 12 of the microneedle 10 is formed from a water-soluble material that dissolves with skin moisture, the protrusion 12 dissolves in the skin, and as a result, the drug contained in the protrusion 12 is fed into the skin. . The type of drug is not particularly limited as long as it is a substance that functions by being administered intradermally. Examples of the drug include pharmacologically active substances and cosmetic compositions. For example, when a substance having a fragrance is used as a medicine, a scent can be imparted to the microneedles 10, so that the microneedles 10 suitable for use as cosmetics can be obtained. The drug may also include a biologic. Biologics are drugs that use raw materials or materials derived from human or animal cells, cell tissues, and the like.

  Note that the medicine to be administered by the microneedle 10 may be included in the protrusion 12 as described above, and sent into the skin along with the dissolution of the protrusion 12, or attached to the surface of the protrusion 12. Then, it may be fed into the skin together with the formation of a hole in the skin by the protrusion 12. Alternatively, a groove or a hole may be formed in the protrusion 12, and the groove or hole may be filled with a medicine, and the medicine may be sent into the skin along with the formation of a hole in the skin by the protrusion 12. Alternatively, before or after the protrusion 12 is stabbed into the skin, a liquid drug may be applied to the skin, and the drug may be sent into the skin from a hole formed by the protrusion 12. Furthermore, the drug may be administered in a form in which these methods are combined. Moreover, when the projection part 12 is formed from the material which has solubility, the water-soluble material which comprises the projection part 12 may function as a chemical | medical agent. The microneedle 10 of the first embodiment may be used in an administration method in which the protrusion 12 is removed from the skin after formation of a hole in the skin, or in an administration method in which the protrusion 12 is embedded in the skin. May be used.

  Here, when the fluidity of the forming material Mt of the microneedle 10 is low, the auxiliary member 20 of the intaglio 30 surrounds the forming material Mt after the forming material Mt is supplied near the recess 31 of the intaglio 30. It may be arranged on the plate material surface 30S. That is, the auxiliary member 20 placement step may be performed after the forming material Mt supply step.

<Forming material filling process>
As shown in FIG. 6, the forming material Mt supplied to the intaglio 30 is filled in the space in the recess 31 and the space on the plate material surface 30 </ b> S so as to cover the overhanging portion 22 of the auxiliary member 20. That is, the inside of the recess 31 is filled with the forming material Mt, and the space surrounded by the standing portion 21 of the auxiliary member 20 is filled with the forming material Mt to the position where the overhanging portion 22 is filled.

  As a filling method of the forming material Mt, a known method may be used. For example, when the forming material Mt is a resin, examples of the filling method include an imprint method, a hot embossing method, an injection molding method, an extrusion molding method, and a casting method. When the forming material Mt is a thermoplastic resin and the forming material Mt is filled by heating and pressurizing the forming material Mt, when the forming material Mt is pressurized at the time of filling, the forming material Mt adheres to the intaglio 30. Easy to peel off the filler. Therefore, when the forming material Mt is filled by pressurization, if the manufacturing method of the first embodiment is used, the effect of facilitating the peeling of the filling from the intaglio 30 is high.

  When the fluidity of the forming material Mt is high, the supply of the forming material Mt to the intaglio 30 and the filling of the forming material Mt may be performed simultaneously. That is, the forming material Mt supplying step and the forming material Mt filling step may be one step.

  Of the filling material Fl that is the filled forming material Mt, the portion located in the recess 31 is the portion that becomes the protrusion 12 of the microneedle 10, and the portion that is located on the plate material surface 30S becomes the substrate 11. Part.

<Peeling process of filling>
As shown in FIG. 7, the overhanging portion 22 is separated from the plate material surface 30 </ b> S of the intaglio plate 30 by pulling up the auxiliary member 20 along the extending direction of the standing portion 21, whereby the filling material Fl is moved away from the intaglio plate 30. Is peeled off. For example, the auxiliary member 20 is pulled up by gripping the end portion or the outer surface of the standing portion 21 and pulling the standing portion 21 along the direction in which the standing portion 21 extends. That is, the auxiliary member 20 is displaced relative to the intaglio 30 along the direction in which the standing portion 21 extends.

  The auxiliary member 20 surrounds the outside of the portion of the filling Fl that becomes the base 11 of the microneedle 10, and the overhanging portion 22 bites into the portion of the base 11, so that the overhanging portion 22 is pulled up. Thus, the filler Fl is also pulled up along the direction in which the standing portion 21 extends. A known peeling technique may be used as a method for peeling the auxiliary member 20 and the filler Fl from the intaglio plate 30. At least a part of the intaglio 30, the auxiliary member 20, and the filler Fl may be cooled or heated before and after the auxiliary member 20 and the filler Fl are peeled from the intaglio 30.

  Here, if the magnitude and direction of the force applied to the filler Fl and the intaglio 30 are not appropriate when the filler Fl is peeled off, the filler Fl may collapse or the intaglio 30 may be damaged. In particular, when the portion that becomes the projection 12 in the filling Fl is lifted obliquely with respect to the extending direction, that is, the depth direction of the recess 31, the surface of the intaglio 30 in the process of lifting the portion that becomes the projection 12. It is easy to happen that the part which becomes the projection part 12 collapses or the intaglio 30 is damaged. If the shape of the protrusion 12 is collapsed by the formed microneedle 10, the perforation performance of the protrusion 12 is deteriorated. In addition, when the intaglio 30 is damaged, the intaglio 30 must be produced again for the production of further microneedles 10, so that the productivity of the microneedle 10 is reduced and the cost required for the production is increased.

  With respect to such a problem, in the manufacturing method of the first embodiment, a force for peeling is applied to the filler Fl through the auxiliary member 20, so that the filler Fl is compared with a method in which the filler Fl is directly grasped and pulled up. Easy to control applied force. And the part used as the projection part 12 can be easily pulled up along the depth direction of the recessed part 31 by pulling up the auxiliary member 20 along the direction where the standing part 21 is extended. Furthermore, the overhanging portion 22 of the auxiliary member 20 has a closed ring shape, and supports the end portion of the portion that becomes the base body 11 in the filling Fl over the entire circumference thereof. At each position in the spreading direction, it is easy to apply a force evenly to the filler Fl through the auxiliary member 20. Therefore, the portion that becomes the protrusion 12 at the time of peeling is preferably suppressed from being pulled in a direction inclined with respect to the depth direction of the recess 31. Therefore, it is easy to peel the filler Fl from the intaglio 30.

  When a biocompatible material is used as a material for forming the microneedles 10, generally, a biocompatible material is expensive. Therefore, it is desired to reduce the amount of material required for forming the microneedles 10. While it is possible to reduce the forming material by reducing the thickness of the base 11, the thinner the base 11, the thinner the portion of the filling Fl stacked on the plate surface 30S of the intaglio 30. Therefore, it becomes more difficult to directly grasp the filler Fl and peel the filler Fl from the intaglio 30. In this regard, in the manufacturing method of the first embodiment, a force for peeling is applied to the filler Fl through the auxiliary member 20, so that the thickness of the substrate 11 is reduced to reduce the material cost, and the filler Fl Coexistence with peeling from the intaglio 30 is also possible.

<Auxiliary member separation process>
As shown in FIG. 8, the filling needle Fl and the auxiliary member 20 are separated, whereby the microneedle 10 that is the filling substance Fl is obtained. A known physical or chemical technique may be used for separating the filler Fl from the auxiliary member 20.

  Further, by cutting or polishing the filler Fl separated from the auxiliary member 20, the outer shape of the base 11 is adjusted, holes, grooves, and the like are formed. The microneedle 10 which is a manufacturing object may be formed. For example, when a plurality of microneedles 10 are collectively formed from one intaglio 30, the filling needle Fl is divided into a plurality of parts including the base body 11 and the protrusions 12, thereby forming the microneedles 10. The

[Detailed configuration of transdermal administration device]
With reference to FIG. 9, the detailed structure of the transdermal administration device manufactured by the above-mentioned manufacturing method is demonstrated.

  As shown in FIG. 9, the base body 11 has a step portion 13 that is located along the outer edge of the base body 11 and that is recessed from the first surface 11 </ b> S. The step portion 13 is a portion where the overhanging portion 22 of the auxiliary member 20 is located before the auxiliary member 20 and the filler Fl are separated in the separation step in the manufacturing method. That is, in the structure composed of the auxiliary member 20 and the filler Fl isolated from the intaglio plate 30 in the peeling step in the manufacturing method, the step portion 13 is the portion where the overhang portion 22 is buried. And in the filling process in the said manufacturing method, the part which was in contact with the plate material surface 30S of the intaglio 30 inside the overhang | projection part 22 in the filling Fl is the 1st surface 11S.

  In other words, a gap is formed between the portion corresponding to the stepped portion 13 and the plate material surface 30S in a state where the surface corresponding to the first surface 11S of the filler Fl and the plate material surface 30S are in contact with each other. Further, the auxiliary member 20 for supporting the portion corresponding to the base body 11 in the relative movement between the filler Fl and the intaglio 30 is located.

  When one microneedle 10 is manufactured using one intaglio 30 and one auxiliary member 20, and the auxiliary member 20 includes a closed annular projecting portion 22, the stepped portion 13 faces the first surface 11S. As seen from the direction in which it is formed, it has a closed annular shape extending along the outer edge of the base 11, and the shape of the first surface 11 </ b> S matches the shape of the region defined by the inner peripheral edge of the overhang portion 22. In addition, when one microneedle 10 is manufactured using one intaglio 30 and one auxiliary member 20, and the auxiliary member 20 includes a cylindrical standing portion 21, the outer shape of the base 11 is the standing portion. This matches the shape of the area defined by the inner peripheral edge of 21.

  The length H of the protrusion 12 is the maximum length of the protrusion 12 along the thickness direction of the base 11, that is, the direction orthogonal to the first surface 11S, and the length of the protrusion 12 from the first surface 11S. The length to the tip. The length H of the protrusion 12 is determined based on the depth of the hole that needs to be formed by the perforation of the protrusion 12 according to the purpose of the perforation by the protrusion 12 and the type of drug to be administered.

  For example, when the target of perforation is human skin and the depth of the hole formed by perforation of the protrusion 12 is set to a length that penetrates the stratum corneum and does not reach the nerve layer, The length H is preferably 200 μm or more and 700 μm or less, more preferably 200 μm or more and 500 μm or less, and further preferably 200 μm or more and 300 μm or less.

  When the depth of the hole is a length that penetrates the stratum corneum and does not reach the nerve layer, the drug can be delivered to a position deeper than the stratum corneum. Since the pores formed in the stratum corneum are closed over time, the stratum corneum serves as a barrier against the outside, so that the drug delivered below the stratum corneum is retained in the living body. Therefore, it is possible to reduce the exfoliation of the drug due to the metabolism of the stratum corneum and the washing of the skin for the purpose of skin care, etc., so that the drug is maintained in the living body for a long period of time. Is done.

  Further, for example, when the depth of the hole is set to a length that remains in the stratum corneum, the length H of the protrusion 12 is preferably 30 μm or more and 300 μm or less, more preferably 30 μm or more and 250 μm or less, More preferably, it is 30 μm or more and 40 μm or less.

  When the depth of the pores is long enough to stay in the stratum corneum, the drug can stay in the stratum corneum. Since the stratum corneum is constantly generated by metabolism, the drug in the stratum corneum is discharged out of the body over time. For this reason, the state in which the medicine is held in the living body can be easily released by, for example, washing the skin or peeling the skin.

  In addition, when the microneedle 10 has the some projection part 12, in the some projection part 12, the length H of each projection part 12 may mutually be the same, and may differ. For example, in the configuration in which the length H of the protrusions 12 arranged on the outer peripheral part among the plurality of protrusions 12 is larger than the length H of the protrusions 12 arranged in the central part, the skin to be administered Is a curved surface, the protrusion 12 tends to contact the skin along the curved surface. In addition, for example, in a configuration in which the length H of the protrusion 12 disposed on the outer peripheral portion among the plurality of protrusions 12 is smaller than the length H of the protrusion 12 disposed on the center, external force is applied. The mechanical strength of the protruding portion 12 at the outer peripheral portion can be increased.

  The width D of the protrusion 12 is the maximum length of the protrusion 12 in the direction parallel to the first surface 11S of the base body 11. The width D of the protrusion 12 is determined according to the required aspect ratio of the protrusion 12, the required hole volume, and the like. The width D of the protrusion 12 is preferably 1 μm or more and 300 μm or less. For example, when the projecting portion 12 has a conical shape or a cylindrical shape, the diameter of a circle that is the bottom surface of the projecting portion 12, that is, the bottom surface in contact with the first surface 11 </ b> S of the base body 11 is the width D of the projecting portion 12. . Further, for example, when the protrusion 12 has a regular quadrangular pyramid shape or a regular quadrangular prism shape, the length of the diagonal line in the square that is the bottom surface of the protrusion 12 in contact with the first surface 11S of the base 11 is the width D of the protrusion 12. It is.

  When the tip of the projection 12 is formed in a sharp shape and a hole having a depth penetrating the stratum corneum is formed by perforation, the tip angle θ of the projection 12 is preferably 5 ° or more and 30 ° or less. It is more preferable that the angle is not less than 20 ° and not more than 20 °. Moreover, when forming the hole of the depth which remains in a stratum corneum by perforation, it is preferable that the front-end | tip angle | corner (theta) of the projection part 12 is 30 degrees or more, and it is more preferable that it is 45 degrees or more.

  The tip angle θ of the protrusion 12 is the maximum value of the angle formed by the tip of the protrusion 12 in the cross section orthogonal to the first surface 11S of the base body 11. For example, when the projecting portion 12 has a regular quadrangular pyramid shape, the tip angle θ of the projecting portion 12 is the apex angle of a triangle having the square diagonal of the bottom surface of the projecting portion 12 as the base and the apex of the regular quadrangular pyramid as the apex.

  In addition, the shape of the projection part 12 is not limited to the shape illustrated by the above-mentioned description, What is necessary is just to determine suitably according to the objective of the perforation | boring by the projection part 12, the kind of chemical | medical agent administered, etc. For example, the purpose of perforation by the protrusion 12 includes the purpose of promoting percutaneous absorption of a drug and the purpose of taking out a substance in the living body through the skin. Moreover, the shape of the protrusion part 12 may be determined from a viewpoint of improving the performance of perforation to the skin.

  And the recessed part 31 of the intaglio 30 used with the above-mentioned manufacturing method is formed so that it may become a hollow of the shape match | combined with the shape of the projection part 12 of formation object. That is, the concave portion 31 is recessed into a shape such as a cone, a pyramid, a cylinder, or a prism, and the inner diameter of the concave portion 31 is, for example, several μm to several hundred μm, and the depth of the concave portion 31 is, for example, several tens μm to several tens μm. 100 μm.

The thickness T, which is the thickness of the entire substrate 11, is the length from the first surface 11S to the second surface 11T. The thickness T of the substrate 11 is preferably 50 μm or more and 1 cm or less.
If the thickness T of the substrate 11 is 50 μm or more, sufficient rigidity of the substrate 11 can be obtained. Therefore, the filler Fl is peeled off from the intaglio plate 30 as the auxiliary member 20 is separated from the plate material surface 30S of the intaglio plate 30. Cheap. On the other hand, if the thickness T of the substrate 11 is 1 cm or less, the substrate 11 is not too thick, and therefore an increase in the time required for supplying and filling the forming material to the intaglio 30 can be suppressed.

  The depth L of the stepped portion 13 is the length of the stepped portion 13 along the thickness direction of the base body 11, that is, in the thickness direction of the base body 11 from the bottom surface of the stepped portion 13 to the first surface 11S. Along the length. The depth L of the stepped portion 13 coincides with the thickness of the overhang portion 22 in the auxiliary member 20 used in the manufacturing process, that is, the length of the overhang portion 22 along the extending direction of the standing portion 21. The depth L of the step portion 13 is preferably 20 μm or more.

  If the depth L of the stepped portion 13 is 20 μm or more, it is easy to secure a large portion where the auxiliary member 20 bites in the filling Fl, and therefore the auxiliary member 20 is separated from the plate material surface 30S of the intaglio plate 30. Accordingly, the filler Fl is easily peeled off from the intaglio 30.

The difference (T−L) between the thickness T of the base 11 and the depth L of the stepped portion 13 is preferably 20 μm or more.
If the difference is 20 μm or more, the rigidity of the portion of the filler Fl that covers the overhanging portion 22 of the auxiliary member 20 is sufficiently obtained, so that the auxiliary member 20 is separated from the plate surface 30S of the intaglio plate 30. As a result, the filler Fl is easily peeled off from the intaglio 30.

  The width W of the stepped portion 13 is the length of the bottom surface of the stepped portion 13 in the direction orthogonal to the extending direction of the stepped portion 13, in other words, when viewed from the direction facing the first surface 11S of the base body 11. This is the shortest distance from the first surface 11S to the outer edge of the base 11 through the step portion 13. The width W of the stepped portion 13 is preferably 0.1 mm or more.

  If the width W of the stepped portion 13 is 0.1 mm or more, it is easy to secure a large portion where the auxiliary member 20 bites in the filling Fl, so that the auxiliary member 20 is separated from the plate surface 30S of the intaglio plate 30. As a result, the filler Fl is easily peeled off from the intaglio 30.

[Modification of auxiliary member]
With reference to FIGS. 10-18, the modification of the auxiliary member 20 used with the manufacturing method of 1st Embodiment is demonstrated. 10, 11, 14, and 15 are plan views of the overhang portion 22 of the auxiliary member 20.
Although the auxiliary member 20 of the above-described embodiment includes the closed annular projecting portion 22, the projecting portion 22 may not be the closed annular shape. When the auxiliary member 20 is arranged on the plate material surface 30S of the intaglio plate 30 in the arrangement step of the above manufacturing method, the overhanging portion 22 is a virtual area surrounding the recess 31 when viewed from the direction facing the plate material surface 30S. What is necessary is just to have the shape which contact | connects the plate material surface 30S in each of two or more points equally distributed on the ring. When there are a plurality of recesses 31, the ring is a virtual ring surrounding a set of all the recesses 31. For example, when the overhanging portion 22 has a closed ring shape, the overhanging portion 22 contacts the plate material surface 30S at each of all points on the virtual ring. In other words, in this case, an arbitrary number of points equally arranged on the virtual ring can be set as points where the projecting portion 22 and the plate material surface 30S are in contact with each other.

  As an example of the shape of the overhang portion 22, as shown in FIG. 10, the overhang portion 22 may have a shape in which the ring is interrupted at one place. In this case, the overhanging portion 22 contacts the plate material surface 30S at each of two or more points equally arranged on the virtual ring. As an example of such a point, FIG. 10 shows a point P together with a ring C which is a virtual ring.

  Moreover, as FIG. 11 shows, the overhang | projection part 22 may have the shape where the ring interrupted in two or more places. That is, the overhang portion 22 may be composed of a plurality of overhang elements 22a. FIG. 11 shows an example in which the overhang portion 22 is composed of two overhang elements 22a. The plurality of projecting elements 22a are arranged on one ring and are separated from each other on the ring. In other words, the overhang portion 22 of the auxiliary member 20 illustrated in FIGS. 2 and 10 is one structure extending along the virtual ring, and the auxiliary member 20 illustrated in FIG. It consists of a plurality of structures located on a typical ring.

  In the case where the overhanging portion 22 is composed of a plurality of overhanging elements 22a, the overhanging elements 22a and the plate material surface 30S are provided for each of the overhanging elements 22a as being equally distributed on the virtual ring. It is possible to set one or more points that are in contact with each other. By these points, the overhanging portion 22 contacts the plate material surface 30S at each of two or more points equally arranged on the virtual ring. As an example of such a point, a point P is shown in FIG.

  In addition, when the overhang | projection part 22 has the shape where the ring interrupted, the standing part 21 is a shape which consists only of the part extended continuously from the overhang | projection part 22, as FIG. 12 shows, for example. The shape may be such that part of the side surface is open along the direction in which the cylinder extends. Alternatively, as shown in FIG. 13, the standing portion 21 has a shape that is connected in an upper region of the portion where the overhang portion 22 is interrupted, that is, an opening that extends from the cylinder end where the overhang portion 22 is located to the side surface. The shape which has this may be sufficient. Alternatively, the standing portion 21 may extend to a position where it comes into contact with the plate material surface 30S at a portion where the overhang portion 22 is interrupted.

  Moreover, when the overhang | projection part 22 is comprised from the some overhang | projection element 22a, the overhang | projection element 22a may be scattered on one ring. For example, in the example shown in FIG. 14, the overhanging portion 22 is composed of two overhanging elements 22 a, and the two overhanging elements 22 a are equally arranged on one ring. In other words, the two projecting elements 22a are arranged at positions facing each other on the ring. In this case, one point where the projecting element 22a and the plate material surface 30S are in contact with each of the projecting elements 22a can be set as the points equally arranged on the virtual ring. And the overhang | projection part 22 touches the plate material surface 30S in each of two points equally distributed on the said virtual ring by the point for every overhang | projection element 22a. As an example of such a point, a point P is shown in FIG.

  The number of the overhang elements 22a is not limited as long as it is possible to set points equally distributed on the virtual ring. For example, as shown in FIG. 15, the overhang portion 22 may be composed of three overhang elements 22 a that are equally arranged on one ring, and the overhang portion 22 includes four or more overhangs. You may be comprised from the element 22a. Even in such a case, as the points equally arranged on the virtual ring, it is possible to set one point where the projecting element 22a and the plate material surface 30S are in contact with each projecting element 22a. As an example of such a point, a point P is shown in FIG.

  In addition, when the overhanging elements 22a are scattered on one ring, the standing portion 21 is configured by a plurality of rectilinear portions 21a that are portions extending from the overhanging elements 22a, for example, as shown in FIG. May be. Alternatively, as shown in FIG. 17, the standing portion 21 has a cylindrical shape that connects a plurality of rectilinear portions 21 a that are portions extending from the overhanging elements 22 a and the plural rectilinear portions 21 a on the side opposite to the overhanging elements 22 a. You may be comprised from the cylinder part 21b.

  If the overhanging portion 22 is configured to come into contact with the plate material surface 30S at each of two or more points equally arranged on a virtual ring surrounding the concave portion 31, the overhanging portion is provided after the filling step of the manufacturing method. Reference numeral 22 denotes an end portion of the portion that becomes the base 11 in the filler Fl, specifically, a portion that becomes the bottom surface of the step portion 13 at a position corresponding to each of the above points. That is, the overhanging portion 22 supports the end portion of the portion that becomes the base 11 in the filler Fl at a position that is substantially evenly distributed along the circumferential direction. Therefore, when pulling up the auxiliary member 20 in the peeling step of the manufacturing method, a force is easily applied to the filler Fl evenly through the auxiliary member 20 at each position in the direction in which the portion that becomes the base 11 spreads. Therefore, since the filler Fl is prevented from being pulled in a direction inclined with respect to the depth direction of the concave portion 31 at the time of peeling, the filler Fl can be easily peeled from the intaglio plate 30. In the above description, the virtual ring is shown as a circular ring, but the shape of the virtual ring is not limited. For example, the shape according to the shape of the region defined by the inner peripheral edge of the standing portion 21 or Any shape that conforms to the outer shape of the substrate 11 may be used, in other words, any shape that conforms to the outer shape of the filler Fl.

  In the case where the standing portion 21 has an opening on the side surface in the portion surrounding the region where the forming material of the microneedle 10 is filled, and the forming material is a material with high fluidity, the auxiliary member 20 In order to prevent the forming material supplied to the inside from leaking out from the opening, a member surrounding the standing portion 21 may be disposed outside the auxiliary member 20 to form the microneedle 10.

  The auxiliary member 20 may be configured by combining two or more members by fitting or the like. For example, the auxiliary member 20 shown in FIG. 18 includes two constituent members 20a. Each component member 20a is composed of approximately ½ portion in the circumferential direction of the standing portion 21 and approximately ½ portion in the circumferential direction of the overhang portion 22, and at the circumferential end of the component member 20a, Concavities and convexities for fitting the constituent members 20a are provided. It is used as one auxiliary member 20 in a state where the two constituent members 20a are fitted. Then, when the auxiliary member 20 and the filler Fl are separated in the separation step in the manufacturing method, the two constituent members 20a are pulled in opposite directions, so that the auxiliary member 20 becomes the two constituent members 20a. Thus, the auxiliary member 20 and the filler Fl are separated. According to such a configuration, since the auxiliary member 20 can be divided, the auxiliary member 20 and the filler Fl can be easily separated.

  When the overhanging portion 22 is not a closed ring, the step portion 13 of the microneedle 10 manufactured by the above manufacturing method is not a closed ring, and has a shape following the shape of the overhanging portion 22. For example, the microneedle 10 shown in FIG. 19 is a microneedle manufactured from one intaglio plate 30 using the auxiliary member 20 including the overhanging portion 22 having a shape in which the ring is interrupted at one place shown in FIG. Needle 10.

  As shown in FIG. 19, the stepped portion 13 extends along the outer edge of the base body 11 and is interrupted at one place on the ring along the outer edge of the base body 11 when viewed from the direction facing the first surface 11S. The first surface 11 </ b> S extends to the outer edge of the base body 11 at the location where the step portion 13 is interrupted. In other words, when viewed from the direction facing the first surface 11S, the first surface 11S, which is a single plane, projects outward at one location on the outer edge of the first surface 11S and reaches the outer edge of the entire base 11. Yes.

  Thus, when viewed from the direction facing the first surface 11S, the stepped portion 13 is formed in the portion where the overhanging portion 22 was located in the manufacturing process, and the portion where the overhanging portion 22 is interrupted is The first surface 11S extends without the step 13 being formed. That is, in the case where the overhanging portion 22 is composed of a plurality of overhanging elements 22a, a step is formed in the portion where the overhanging element 22a is located in the manufacturing process as seen from the direction facing the first surface 11S. A portion 13 is formed, and the first surface 11S is formed in the portion between the projecting elements 22a adjacent to each other without the step portion 13 being formed.

  In the case where the overhanging portion 22 is not closed, the auxiliary member 20 and the filling Fl can be separated from the filling Fl in the separation step since the auxiliary member 20 can be separated from the filling Fl starting from the interrupted portion of the overhanging portion 22. Is easily separated.

As described above, according to the method for manufacturing a transdermal administration device and the transdermal administration device of the first embodiment, the following effects can be obtained.
(1) Since a force for peeling is applied to the filler Fl through the auxiliary member 20, it is easier to control the force applied to the filler Fl compared to a method of directly grabbing the filler Fl and peeling it from the intaglio plate 30. Then, by pulling up the auxiliary member 20 along the extending direction of the upright portion 21, it is possible to easily pull up the filling material Fl along the depth direction of the recessed portion 31. It is possible to prevent the filler Fl and the intaglio 30 from being damaged by being pulled in a direction inclined with respect to the depth direction. In particular, since the overhanging portion 22 supports the end portion of the filler Fl at a position that is substantially evenly distributed along the circumferential direction, when the auxiliary member 20 is pulled up, each of the extending directions of the filler Fl It is easy to apply force evenly to the position. Therefore, it is possible to suppress the filler Fl from being pulled in a direction inclined with respect to the depth direction of the concave portion 31 during peeling. Thus, according to the manufacturing method of 1st Embodiment, since control of the magnitude | size and direction of the force added to the filling Fl and the intaglio 30 at the time of peeling is easy, the filling Fl is peeled from the intaglio 30. Cheap.

  (2) When the filler Fl and the auxiliary member 20 are separated in the separation step, the transdermal administration device 100 using the filler Fl suitably peeled off from the intaglio as an administration part is obtained. Therefore, the transdermal administration device 100 including an administration part with good shape accuracy and surface condition is obtained.

  (3) In the configuration in which the overhang portion 22 is a single structure extending along a virtual ring, it is easy to ensure a large portion of the filler Fl supported by the overhang portion 22 during peeling. Therefore, the filler Fl and the auxiliary member 20 can be peeled from the intaglio 30 in a state where the filler Fl is stably supported by the auxiliary member 20. On the other hand, in the configuration in which the overhang portion 22 is composed of a plurality of structures positioned on a virtual ring, in the separation step, the auxiliary member 20 is used as the filler Fl starting from the portion where the overhang portion 22 is interrupted. Therefore, the auxiliary member 20 and the filler Fl can be easily separated from each other. Moreover, it is easy to ensure the 1st surface 11S in the base | substrate 11 of the administration part formed widely. Therefore, in particular, when the first surface 11S of the substrate 11 is pressed against the skin for drug administration and the protrusion 12 is pierced into the skin, the position of the substrate 11 with respect to the skin is easy to stabilize, and the protrusion 12 is accurately placed on the skin. Easy to bite into.

  (4) In the manufacturing method in which the forming material supply step of the administration part is performed after the auxiliary member 20 arranging step, the auxiliary member 20 is arranged on the plate material surface 30S of the intaglio plate 30 in a state where the forming material is not arranged. Therefore, it is easy to align the auxiliary member 20 on the plate material surface 30S. On the other hand, in the manufacturing method in which the arranging step of the auxiliary member 20 is performed after the forming material arranging step, compared with the manufacturing method in which the forming material is supplied to a minute space surrounded by the standing portion 21 after the auxiliary member 20 is arranged. , Supply of the forming material is easy.

  (5) In the manufacturing method in which the forming material of the administration part is a resin, and the forming material is filled by pressurization in the filling step, the forming material is likely to be in close contact with the intaglio plate 30 and it is difficult to peel off the filler Fl. . Therefore, when the forming material Mt is filled by pressurization, if the manufacturing method of the first embodiment is used, the effect of facilitating the peeling of the filler Fl from the intaglio 30 is high.

  (6) In the configuration in which the auxiliary member 20 includes a portion made of metal, it is easy to obtain the auxiliary member 20 having high mechanical strength. Therefore, it is easy to realize the auxiliary member 20 suitable for being gripped or pulled up in the peeling process. In general, since the resin material has higher flexibility than the metal material, in the configuration in which the portion including the surface in contact with the plate material surface 30S in the placement process in the projecting portion 22 is made of resin, the portion is made of metal. Compared with the structure which becomes, the adhesiveness of the auxiliary member 20 arrange | positioned at the intaglio 30 and the plate material surface 30S is improved. Therefore, the forming material is easily filled in the region surrounded by the auxiliary member 20 without leakage.

(Second Embodiment)
With reference to FIGS. 20-24, 2nd Embodiment of the manufacturing method of a transdermal administration device and the transdermal administration device manufactured by this manufacturing method is described.

[Configuration of transdermal administration device]
A configuration of a transdermal administration device which is a production target of the production method of the second embodiment will be described. The transdermal administration device produced by the production method of the second embodiment is composed of an administration part and an auxiliary member. That is, in the manufacturing method of the second embodiment, the filler Fl and the auxiliary member 20 are not separated.

  The auxiliary member 20 is used, for example, as a member for attaching the transdermal administration device to an instrument that assists administration of a drug by the transdermal administration device. Examples of the instrument include a syringe having a function of supplying a drug toward a transdermal administration device and an applicator having a function of assisting skin perforation by the protrusion 12. The applicator may have, for example, a part that functions as a handle when the user pierces the protrusion 12 into the skin, or includes a mechanism that applies a biasing force to pierce the skin. May be.

  In addition, the transdermal administration device is attached to an apparatus for performing various treatments such as sterilization on the transdermal administration device, an apparatus for performing various analyzes using the penetration of the transdermal administration device into the skin, and the like. Alternatively, the auxiliary member 20 may be used as a member for attaching a transdermal administration device to such an apparatus.

  Further, for example, the auxiliary member 20 is arranged at the time of packaging and transporting the transdermal administration device, the arrangement position when the transdermal administration device is used in combination with other devices when using the transdermal administration device, etc. You may function as a member which shows the mark for determining the arrangement position of a transdermal administration device.

Further, for example, the auxiliary member 20 may function as a portion that is supported when the transdermal administration device is transported or used.
With reference to FIG. 20 and FIG. 21, the structure of the transdermal administration device 110 provided with the microneedle 10 which is an example of an administration part, and the auxiliary member 20 is demonstrated. The form of the microneedle 10 is the same as that of the first embodiment. The form of the auxiliary member 20 may be any of the various forms described in the first embodiment. 20 and 21, as an example, a configuration in which the transdermal administration device 110 includes the auxiliary member 20 in which the overhanging portion 22 has a closed ring shape is illustrated.

  As shown in FIGS. 20 and 21, the base body 11 of the microneedle 10 has a stepped portion 13 that is recessed from the first surface 11 </ b> S at a position along the outer edge of the base body 11. The overhanging portion 22 of the auxiliary member 20 fills the step portion 13 and forms a single plane together with the first surface 11S. That is, the portion of the overhanging portion 22 that is located closest to the tip end side of the protruding portion 12 is formed in a planar shape, and the position of the first surface 11S and the overhanging portion 22 in the thickness direction of the base body 11 are formed. The position of the surface on the tip side of the protrusion 12 coincides.

  When viewed from the direction facing the first surface 11 </ b> S, the region where the overhanging portion 22 is located includes two or more points equally arranged on a virtual ring surrounding the protruding portion 12. When the microneedle 10 includes a plurality of protrusions 12, this virtual ring is a ring that surrounds a set of all the protrusions 12. When the overhanging portion 22 has a closed ring shape, the region where the overhanging portion 22 is located includes all points on the virtual ring. In other words, in this case, any number of points equally distributed on the virtual ring can be set as the points included in the region where the overhanging portion 22 is located.

The standing portion 21 of the auxiliary member 20 extends from the projecting portion 22 to the side opposite to the protruding portion 12 and is in contact with the base body 11 outside the base body 11.
As another example of the transdermal administration device 110, FIG. 22 shows an auxiliary member 20 in which the overhang portion 22 is composed of two overhang elements 22a, and the standing portion 21 is composed of two rectilinear portions 21a. The structure with which the skin administration device 110 is provided is shown. In this case, the step part 13 is arrange | positioned in two places which mutually face on one ring, and it is filled with the overhang | projection element 22a in each of two places. The two overhanging elements 22a form one plane together with the first surface 11S.

  In such a configuration, one point can be set for each region where the overhanging element 22a is located as the points equally arranged on the virtual ring. And the area | region where the overhang | projection part 22 is located in the direction facing the 1st surface 11S by the point for every overhang | projection element 22a contains two points equally distributed on the said virtual ring It is.

  If it is possible to set points that are equally distributed on the virtual ring, as described in the first embodiment, the overhanging portion 22 may have a shape in which the ring is interrupted at one or more points. Alternatively, it may be composed of three or more projecting elements 22a scattered on one ring. Regardless of the configuration of the overhanging portion 22, the stepped portion 13 is disposed at a position along the outer edge of the base body 11, and the overhanging portion 22 fills the stepped portion 13, together with the first surface 11 </ b> S. One plane is formed.

  Since the auxiliary member 20 of the second embodiment constitutes a transdermal administration device 110 together with the microneedle 10 and is used for administration of a drug from the skin, the auxiliary member 20 is preferably formed of a biocompatible material.

  Further, in the first embodiment, it has been described that the auxiliary member 20 may be subjected to a surface treatment for easily separating the auxiliary member 20 from the filler Fl. In the embodiment, the auxiliary member 20 may be subjected to a surface treatment for improving the adhesion between the auxiliary member 20 and the microneedle 10 as the filler Fl. Specifically, as the surface treatment, for example, in order to provide fine irregularities on the surface of the auxiliary member 20, various kinds of special processing, sandblast treatment, plasma treatment, and the like can be performed.

[Modification of auxiliary member]
The auxiliary member 20 may have a structure corresponding to the function of the auxiliary member 20 described above. For example, as illustrated in FIGS. 23 and 24, the auxiliary member 20 includes a protruding portion 23 that protrudes on the outer surface of the standing portion 21 to the opposite side of the protruding portion 22 with respect to the standing portion 21. Also good.

  The protrusion 23 is, for example, a structure for attaching the transdermal administration device 110 to another instrument or apparatus. For example, the protrusion 23 constitutes a screw thread, and the transdermal administration device 110 is attached to another instrument or apparatus by screwing the protrusion 23 with a screw groove provided in another instrument or apparatus. Thereby, the auxiliary member 20 functions as a member for attaching the transdermal administration device 110 to another instrument or apparatus. In addition, for example, the transdermal administration device 110 may be attached to another instrument or apparatus by fitting the auxiliary member 20 with another instrument or apparatus using the protruding portion 23. Reference numeral 20 functions as a member for attaching the transdermal administration device 110 to another instrument or apparatus.

  Further, for example, the protrusion 23 may function as a mark for determining the arrangement position of the transdermal administration device 110, or may function as a portion that is supported when the transdermal administration device 110 is transported or used. Good.

  Thus, the protrusion 23 should just have the shape, size, and arrangement according to the use of the protrusion 23. In the example shown in FIG. 23 and FIG. 24, the protruding portion 23 is disposed at a position close to the end portion where the protruding portion 22 is located among both end portions in the extending direction of the standing portion 21, but is not limited thereto. Instead, the protruding portion 23 may be disposed in the vicinity of the end portion of the standing portion 21 opposite to the overhang portion 22.

  In addition, also in the manufacturing method of 1st Embodiment, the auxiliary member 20 provided with the protrusion part 23 may be used. For example, the protrusion 23 may be used as a portion that is gripped when the filler Fl and the auxiliary member 20 are pulled up in the peeling process of the filler Fl.

[Method of manufacturing transdermal administration device]
The manufacturing method of the transdermal administration device of the second embodiment is the same as that of the first embodiment except that it does not have a separation step. That is, as in the first embodiment, the intaglio 30 production process, the auxiliary member 20 arrangement process, and the forming material Mt supply process are performed. As described in the first embodiment, the order of the auxiliary member 20 arranging step and the forming material Mt supplying step is not limited.

  Further, similarly to the first embodiment, a filling process of the forming material Mt and a peeling process of the filler Fl are performed. The filler Fl peeled off from the intaglio plate 30 by the peeling process is the microneedle 10, and the structure composed of the peeled filler Fl and the auxiliary member 20 is the transdermal administration device 110. That is, in the manufacturing method of the second embodiment, the microneedle 10 and the auxiliary member 20 as the filler Fl are included in the transdermal administration device 110 as an integral structure separated from the intaglio 30.

  In addition, the process for improving the adhesiveness of the auxiliary member 20 and the microneedle 10 may be performed before or after the filling step and before or after the peeling step. Examples of the process for improving the adhesion include a process using a chemical action such as application of an adhesive to a portion of the auxiliary member 20 in contact with the filler Fl, and a process such as thermal welding or laser welding. It is done.

  In the manufacturing method of the second embodiment, one transdermal administration device 110 is formed from the filler Fl pulled up from one intaglio 30 together with one auxiliary member 20 and the auxiliary member 20.

  As described above, according to the method for manufacturing a transdermal administration device and the transdermal administration device of the second embodiment, in addition to the effects (1) and (3) to (6) of the first embodiment, The effect is obtained.

  (7) The auxiliary member 20 which is a member for assisting the peeling of the filler Fl is used as a member constituting the transdermal administration device 110 together with the administration unit. Therefore, in the manufacturing process of the transdermal administration device 110, a process of separating the filler Fl and the auxiliary member 20 is unnecessary. In addition, the process of assembling the member is compared with the manufacturing method in which the member constituting the transdermal administration device 110 as a member different from the auxiliary member 20 is assembled to the administration part after the filling Fl and the auxiliary member 20 are separated. Reduction is possible. Therefore, the manufacturing process of the transdermal administration device 110 can be simplified, and the cost required for manufacturing can be reduced.

[Modification]
The above embodiments can be implemented with the following modifications.
-As FIG. 25 shows, the auxiliary member 20 may have a part comprised from a mutually different material. For example, the auxiliary member 20 includes a metal part 24 made of metal and a resin part 25 made of resin. The metal part 24 constitutes the standing part 21 and a part of the overhang part 22, and the resin part 25 constitutes a part of the overhang part 22. Specifically, the overhanging portion 22 is composed of two portions arranged along the extending direction of the standing portion 21. Of these, the metal portion 24 constitutes a portion close to the standing portion 21, The resin portion 25 constitutes a portion far from the portion 21, that is, a portion including a surface in contact with the plate material surface 30 </ b> S of the intaglio 30.

  According to such a configuration, since the standing portion 21 that is a portion that is gripped or pulled and the protruding portion 22 in the vicinity thereof are made of metal in the peeling process, the mechanical strength at this portion is increased. Therefore, it is easy to realize the auxiliary member 20 having a strength suitable for being applied with a force in the peeling process. On the other hand, since the portion of the overhanging portion 22 that contacts the plate material surface 30S of the intaglio 30 is made of resin, the auxiliary member 20 disposed on the intaglio 30 is compared with the configuration in which the portion is made of metal. Adhesion with the plate material surface 30S is enhanced. Therefore, the forming material is easily filled in the region surrounded by the auxiliary member 20 without leakage.

  In particular, when the intaglio 30 is made of metal, the intaglio 30 itself is less flexible than the case where the intaglio 30 is made of resin, and the adhesion between the auxiliary member 20 and the plate material surface 30S tends to be low. For this reason, the effect of the portion including the surface in contact with the plate material surface 30 </ b> S in the overhang portion 22 being made of resin is great.

  -As FIG. 26 shows, the base | substrate 11 may have the recessed part depressed from the 2nd surface 11T, or may have the convex part protruded from the 2nd surface 11T. For example, when the indenter 30 is filled with the forming material of the microneedle 10, such a concave portion or convex portion presses the forming material by pressing a mold having concave and convex portions in which the concave portion and convex portion to be formed are inverted. Formed by. In such a base body 11, the first surface 11 </ b> S is a flat surface located closest to the tip of the protrusion 12 in the base body 11, and the second surface 11 </ b> T is the first surface in the thickness direction of the base body 11. It is a flat surface located at a position farthest from 11S.

  -The shape of the projection part 12 which an administration part has is not restricted to needle shape, ie, the shape where the length of the thickness direction of the base | substrate 11 is longer than the length of the direction along the 1st surface 11S of the base | substrate 11. FIG. The shape of the protrusion 12 is blade-shaped, that is, the length in one extending direction, which is the direction along the first surface 11S of the base body 11, is longer than the length in the thickness direction of the base body 11, and The tip may be formed in a linear shape extending in a direction different from the direction orthogonal to the first surface 11S of the base body 11, for example, a direction along the extending direction. For example, the projecting portion 12 has a triangular prism shape extending in the extending direction, and one of three rectangular side surfaces of the triangular prism is in contact with the base body 11 and a side that divides the other two side surfaces is formed. You may have the shape which functions as a front-end | tip of the projection part 12. As shown in FIG.

(Appendix)
Means for solving the above-mentioned problems include the following supplementary notes as technical ideas derived from the above-described embodiment and the above-described modifications.

  An intaglio plate comprising a base having a first surface that is a flat surface and a dosing portion comprising a protrusion protruding from the first surface, wherein the first surface has a hollow shape following the shape of the protrusion. A transdermal administration device that is a surface for contacting the plate surface of the substrate, wherein the base has a stepped portion extending along an outer edge of the base and recessed from the first surface, When viewed from the direction facing the first surface, the first surface is interrupted at one or more locations on the ring along the outer edge of the substrate and the step portion is interrupted. And a shape for forming a gap between the step portion and the plate material surface in a state where the first surface and the plate material surface are in contact with each other. In the relative movement of the base and the intaglio along the protruding direction, the base Percutaneous administration device which is a space for the auxiliary member is positioned to support the.

[Example]
The transdermal administration device and the manufacturing method thereof will be described using specific examples and comparative examples.

<Example 1>
(Intaglio production process)
A microneedle master was prepared by precision machining. Using a silicon substrate as a material for forming the original plate, an original plate is produced in which 100 square pyramid (height: 120 μm, bottom surface: 38 μm × 38 μm) protrusions are arranged in a grid of 10 columns and 10 rows at 1 mm intervals. did. The 100 protrusions were arranged in a square area having a side of about 9 mm.

Next, the shape of the protrusion part of the original plate was transferred by electroforming, and a nickel intaglio plate in which the unevenness of the original plate was inverted was produced.
(Auxiliary member placement process)
As an auxiliary member, an auxiliary member having a projecting portion having a closed ring shape and a standing portion having a cylindrical shape was prepared. When viewed from the direction along the extending direction of the standing portion, the area defined by the inner peripheral edge of the overhanging portion and the inner peripheral edge of the standing portion is circular, and the outer shape of the overhanging portion and the outer shape of the standing portion are rectangular. is there. The length of the auxiliary member in the extending direction of the standing portion is 30 mm, and the outer shape of the overhanging portion and the outer shape of the standing portion are 30 mm × 30 mm squares. The inner diameter of the overhanging portion, that is, the diameter of the circular opening defined by the inner peripheral edge of the overhanging portion is 15 mm, and the inner diameter of the standing portion, that is, the standing opening when viewed from the direction along the extending direction of the standing portion. The diameter of the circular area that the installation part defines is 25 mm. The auxiliary member is composed of two components having the same shape, and can be separated into each of these components in the circumferential direction of the overhanging portion. Also, the vicinity of the end of the overhang, that is, the portion of the overhang that is in contact with the plate surface of the intaglio plate is formed of silicone resin, and the other portion of the overhang and the standing portion are made of stainless steel. Is formed.

  In the auxiliary member arranging step, the auxiliary member is placed on the plate so that the overhanging portion of the auxiliary member is arranged at a position surrounding the whole of the plurality of concave portions of the intaglio when viewed from the direction facing the plate material surface of the intaglio. Arranged on the surface.

(Forming material placement process and forming material filling process)
A thermoplastic acrylic resin was used as the material for forming the microneedles, and this acrylic resin was disposed on the intaglio plate surface in a region surrounded by the auxiliary member. Then, the placed acrylic resin was pressurized while being heated, and the acrylic resin was filled into the space surrounded by the auxiliary member on the plate material surface so as to cover the overhanging portion.

(Packing peeling process)
By pulling up the auxiliary member perpendicularly to the plate surface, the filling of the forming material and the auxiliary member were peeled from the intaglio. When the auxiliary member was pulled up, the filler did not fall away from the auxiliary member, and the filler and the auxiliary member could be peeled from the intaglio. Thereby, the transdermal administration device of Example 1 comprised from the microneedle which is a filler, and an auxiliary member was obtained. When the peeled microneedles and the intaglio after peeling were observed, the shape of the protrusions was not broken and the intaglio was not damaged.

<Example 2>
In the same procedure as in Example 1, an intaglio making process, an auxiliary member arranging process, a forming material arranging process, a forming material filling process, and a filling material peeling process are performed, and the filling material and the auxiliary member are formed. A structure was obtained. Subsequently, as a step of separating the auxiliary member, the auxiliary member was divided into two constituent members and separated from the filler, and the filler and the auxiliary member were separated. Thereby, the transdermal administration device of Example 2 consisting of microneedles which were separated packings was obtained. In the microneedle of Example 2, the thickness of the entire substrate was 5 mm, the depth of the step portion was 2 mm, and the width of the step portion was 5 mm.

<Comparative Example 1>
(Intaglio production process)
An intaglio plate having recesses having the same shape and arrangement as in the example was produced in the same procedure as in the example.

(Forming material placement process and forming material filling process)
A thermoplastic acrylic resin was used as the material for forming the microneedles, and the acrylic resin was disposed on the concave portion of the intaglio without the auxiliary member being disposed on the intaglio plate surface. Then, the placed acrylic resin was pressurized while being heated, and the acrylic resin was filled into the recess and the space on the plate surface.

(Packing peeling process)
In the filling of the forming material, a portion located on the plate material surface of the intaglio was picked up with tweezers, and the filler was pulled up perpendicularly to the plate material surface. However, the filler and the intaglio were in close contact, and the filler could not be peeled from the intaglio. Therefore, the tip of the tweezers was inserted between the filling and the plate material surface to peel the filling from the intaglio. As a result, the intaglio was damaged when the tip of the tweezers touched the surface of the intaglio. Furthermore, as a result of the protrusions that are filled in the recesses being pulled up obliquely with respect to the plate material surface, the protrusions contact the surface of the intaglio in the process of peeling, and the shape of the protrusions collapses The intaglio was damaged.

  As a result, a transdermal administration device that was a microneedle of a comparative example was obtained, but as described above, the filler could not be peeled while suppressing damage to the protrusions and the intaglio.

  DESCRIPTION OF SYMBOLS 10 ... Microneedle, 11 ... Base | substrate, 11S ... 1st surface, 11T ... 2nd surface, 12 ... Projection part, 13 ... Step part, 20 ... Auxiliary member, 20a ... Constituent member, 21 ... Standing part, 22 ... Tension Projection part, 22a ... projecting element, 23 ... projection part, 24 ... metal part, 25 ... resin part, 30 ... intaglio, 30S ... plate material surface, 31 ... recess, 100, 110 ... transdermal administration device.

Claims (12)

A method for producing a transdermal administration device comprising an administration part having a substrate having a first surface and a protrusion protruding from the first surface,
A placement step of placing an auxiliary member on the plate material surface using an intaglio plate having a recess having a concave shape following the shape of the protrusion, on the plate material surface, wherein the auxiliary member includes a standing portion and a tension member And the protruding portion extends in the depth direction of the concave portion, and the overhang portion is on a virtual ring surrounding the concave portion as viewed from the direction facing the plate material surface. It is in contact with the plate material surface at each of two or more arranged points, and from the end located on the plate material surface side of the both ends of the standing portion in the depth direction to the inside of the ring Projecting toward the said placement step;
A filling step of filling the forming material into the space in the recess and the space on the plate material surface so that the forming material of the administration part covers the overhanging part;
The auxiliary member is displaced relative to the intaglio plate along the extending direction of the upright portion, and the overhanging portion is separated from the plate material surface, whereby the filler made of the forming material is removed from the intaglio plate. A peeling step for peeling;
A method for producing a transdermal administration device comprising: After the peeling step,
The method for manufacturing a transdermal administration device according to claim 1, further comprising a separation step of separating the filler and the auxiliary member. The method for producing a transdermal administration device according to claim 1, wherein the administration unit and the auxiliary member, which are the filler, are included in the transdermal administration device as an integrated structure separated from the intaglio. The method of manufacturing a transdermal administration device according to any one of claims 1 to 3, wherein the overhang portion is a single structure extending along the ring. The method of manufacturing a transdermal administration device according to any one of claims 1 to 3, wherein the overhanging portion is composed of a plurality of structures positioned on the ring. The method for manufacturing a transdermal administration device according to any one of claims 1 to 5, wherein a supply step of supplying the forming material to the plate surface is performed after the arrangement step. The method for manufacturing a transdermal administration device according to any one of claims 1 to 5, wherein the arranging step is performed after the supplying step of supplying the forming material to the plate surface. The forming material is a resin,
The method for manufacturing a transdermal administration device according to any one of claims 1 to 7, wherein in the filling step, the forming material is filled by pressurization. The method for manufacturing a transdermal administration device according to any one of claims 1 to 8, wherein the auxiliary member includes a metal part. The auxiliary member includes a portion made of resin,
The method for manufacturing a transdermal administration device according to any one of claims 1 to 9, wherein the portion made of the resin includes a surface in contact with the plate surface in the arrangement step in the overhanging portion. A transdermal administration device comprising an administration part comprising a substrate having a first surface that is a single plane and a protrusion protruding from the first surface,
The base has a stepped portion extending along the outer edge of the base and recessed from the first surface,
The step portion is interrupted at one location on the ring along the outer edge of the base body as viewed from the direction facing the first surface, and at the location where the step portion is interrupted, the first surface Extending to the outer edge of the substrate. A dosing unit comprising a base having a first surface, the base having a stepped portion located along the outer edge of the base and recessed from the first surface, and a protrusion protruding from the first surface When,
An auxiliary member comprising an overhanging portion that fills the stepped portion and forms a single plane with the first surface, and an upright portion that extends from the overhanging portion and contacts the base on the outside of the base;
With
The region where the overhanging part is located when viewed from the direction facing the first surface includes two or more points equally distributed on a virtual ring surrounding the protruding part.